AMAG Group
Warranty Specialist(m/w/x)
Full-timeWith HomeofficeExperienced
Daillens, Cham
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DEDentsply Sirona
Complaint & PMS Specialist(m/w/x)
Ballaigues
Full-timeWith Home OfficeJunior
Nejo AI Summary
Overseeing complaint handling workflow and assigning investigations for dental products. 1-3 years post-market surveillance experience required. 25 days annual leave, flexible hours, and subsidized meals.
Requirements
- Bachelor’s degree, Associate degree, or equivalent education/work experience
- 1-3 years post-market surveillance and complaint management experience
- English B2 minimum
- French B2 minimum
- German knowledge is an asset
- Advanced Excel skills
- Confident with Microsoft suite (Word, PowerPoint)
- Experience with Trackwise or smartsolve is a plus
- Ability to work autonomously and accurately
- Great attention to details
- Strong organizational planning skills
- Strong analytical skills
- Results oriented
- Eligible to work in the country of position
Tasks
- Oversee complaint handling workflow for regulatory compliance and timeliness
- Assign complaint investigations to Complaint Investigators based on complexity, product, and risk
- Support product returns and credit note processing
- Prepare and submit blocking requests for impacted products and platforms
- Collaborate with Quality, Regulatory, and Supply Chain on blocking decisions
- Create and maintain pre-HHE and HHE documentation
- Assess complaint data to identify potential safety or compliance risks
- Ensure traceability between complaints, investigations, and HHE decisions
- Prepare and submit vigilance reports (e.g., MIR) in accordance with regulations
- Coordinate responses to requests from Competent Authorities and Notified Bodies
- Coordinate follow-up, final, and trend-related vigilance submissions
- Serve as primary interface with Global CHU for vigilance alignment
- Support Complaint Supervisor for recall and market action activities
- Ensure regulatory notifications, execution tracking, and effectiveness monitoring
- Coordinate recall activities across legal and physical manufacturing sites
- Perform and maintain PMS and PSUR activities in accordance with MDR and jurisdictional requirements
- Collect, analyze, and trend post-market data from complaints, vigilance, sales, and other sources
- Maintain PMS documentation, plans, and reports
- Support periodic risk evaluations and country-specific PMS requirements
- Prepare PSC meeting materials, including data extraction, trend analysis, and risk summaries
- Perform PSC analyses and recommendations
- Track PSC actions and ensure implementation and follow-up
- Prepare and maintain complaint, vigilance, and PMS KPIs
- Perform data extraction and analysis for Regulatory, R&D, Marketing, Quality, and Management
- Provide structured datasets and interpretations to support decision-making
- Support audit/inspections as needed
Work Experience
- 1 - 3 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
- French – Business Fluent
- German – Basic
Tools & Technologies
- Excel
- Microsoft Word
- Microsoft PowerPoint
- Trackwise
- smartsolve
Benefits
Flexible Working
- Flexible working hours
- Hybrid working
Other Benefits
- Attractive LPP benefits
- Comprehensive induction
Free or Subsidized Food
- Subsidized meals
Snacks & Drinks
- Coffee allowance
Healthcare & Fitness
- Company sports and leisure activities
Learning & Development
- Further training opportunities
- LinkedIn Learning access
Mentorship & Coaching
- Global mentoring and coaching program
Mental Health Support
- Global employee assistance program
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Dentsply Sirona and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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DEDentsply Sirona
Complaint & PMS Specialist(m/w/x)
Ballaigues
Full-timeWith Home OfficeJunior
Nejo AI Summary
Overseeing complaint handling workflow and assigning investigations for dental products. 1-3 years post-market surveillance experience required. 25 days annual leave, flexible hours, and subsidized meals.
Requirements
- Bachelor’s degree, Associate degree, or equivalent education/work experience
- 1-3 years post-market surveillance and complaint management experience
- English B2 minimum
- French B2 minimum
- German knowledge is an asset
- Advanced Excel skills
- Confident with Microsoft suite (Word, PowerPoint)
- Experience with Trackwise or smartsolve is a plus
- Ability to work autonomously and accurately
- Great attention to details
- Strong organizational planning skills
- Strong analytical skills
- Results oriented
- Eligible to work in the country of position
Tasks
- Oversee complaint handling workflow for regulatory compliance and timeliness
- Assign complaint investigations to Complaint Investigators based on complexity, product, and risk
- Support product returns and credit note processing
- Prepare and submit blocking requests for impacted products and platforms
- Collaborate with Quality, Regulatory, and Supply Chain on blocking decisions
- Create and maintain pre-HHE and HHE documentation
- Assess complaint data to identify potential safety or compliance risks
- Ensure traceability between complaints, investigations, and HHE decisions
- Prepare and submit vigilance reports (e.g., MIR) in accordance with regulations
- Coordinate responses to requests from Competent Authorities and Notified Bodies
- Coordinate follow-up, final, and trend-related vigilance submissions
- Serve as primary interface with Global CHU for vigilance alignment
- Support Complaint Supervisor for recall and market action activities
- Ensure regulatory notifications, execution tracking, and effectiveness monitoring
- Coordinate recall activities across legal and physical manufacturing sites
- Perform and maintain PMS and PSUR activities in accordance with MDR and jurisdictional requirements
- Collect, analyze, and trend post-market data from complaints, vigilance, sales, and other sources
- Maintain PMS documentation, plans, and reports
- Support periodic risk evaluations and country-specific PMS requirements
- Prepare PSC meeting materials, including data extraction, trend analysis, and risk summaries
- Perform PSC analyses and recommendations
- Track PSC actions and ensure implementation and follow-up
- Prepare and maintain complaint, vigilance, and PMS KPIs
- Perform data extraction and analysis for Regulatory, R&D, Marketing, Quality, and Management
- Provide structured datasets and interpretations to support decision-making
- Support audit/inspections as needed
Work Experience
- 1 - 3 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
- French – Business Fluent
- German – Basic
Tools & Technologies
- Excel
- Microsoft Word
- Microsoft PowerPoint
- Trackwise
- smartsolve
Benefits
Flexible Working
- Flexible working hours
- Hybrid working
Other Benefits
- Attractive LPP benefits
- Comprehensive induction
Free or Subsidized Food
- Subsidized meals
Snacks & Drinks
- Coffee allowance
Healthcare & Fitness
- Company sports and leisure activities
Learning & Development
- Further training opportunities
- LinkedIn Learning access
Mentorship & Coaching
- Global mentoring and coaching program
Mental Health Support
- Global employee assistance program
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Dentsply Sirona and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Dentsply Sirona
Industry
Healthcare
Description
Das Unternehmen ist der weltweit größte Anbieter von Dentalprodukten und -technologien und unterstützt Zahnärzte und Zahntechniker.
Not a perfect match?
- AMAG Group
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